Primary Management of Irritable Bowel Syndrome

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1 Primary Management of Irritable Bowel Syndrome Jasmine Zia, MD Acting Instructor, Division of Gastroenterology Current Concepts in Drug Therapy CME Course April 23, 2015 Irritable Bowel Syndrome (IBS) ROME III Criteria: Recurrent abdominal pain/discomfort at least 3 days/month in last 3 months associated with two or more of the following: 1. Improvement with defecation 2. Onset associated with change in stool frequency 3. Onset associated with a change in form (appearance of stool) *In absence of selected alarm features Rome III Diagnostic Criteria for FGIDs Epidemiology of IBS Affects up to 20% of the US population Top ten reasons why patients seek primary care 30 50% of gastroenterology consultations Drossman et al. AJG 95(4) (2000): Elsenbruch S. Brain, Behavior, and Immunity 2011;25: Chey et al. Gut Liver 2011;5:

2 You diagnose a previously healthy 26 year old female with post infectious irritable bowel syndrome, subtype diarrhea (IBS D). Which of the following pharmacological agent has NOT been shown to be effective at reducing IBS D symptoms? 1. Antispasmodics (Dicyclomine, Hyoscyamine) 2. Loperamide 3. Ondansetron 4. Cromolyn sodium 5. Placebo Antispasmodics Certain antispasmotics (hyoscine, cimetropium, pinaverium) may provide short term relief of abdominal pain/discomfort in IBS (Grade 2C). Most effective in IBS patients with: Crampy abdominal pain and diarrhea Intermittent, meal related symptoms. Evidence for long term efficacy not available (Grade 2B) Evidence for safety and tolerability limited (Grade 2C) Significant side effects: dry mouth, dizziness, blurry vision, confusion, urinary retention, constipation. AVOID in elderly Chey et al. Gut Liver 2011;5: Antispasmodics Bentyl 10mg PO QID AC Titrate up to 20mg PO QID AC Levsin 0.125mg SL QID AC Titrate up to 0.25mg SL QID AC as tolerated Antidiarrheals: Loperamide Effective agent for the treatment of diarrhea, reducing stool frequency and improving stool consistency (Grade 2C). Not more effective than placebo at reducing pain, bloating or global symptoms. RCTs comparing loperamide with other antidiarrheals have not been performed. Safety and tolerability data lacking. 2

3 5HT 3 Antagonist: Ondasetron Significantly improved stool consistency, urgency and frequency. Main benefit seen within 7 days. Median dose = 4 mg per day Slows down the accelerated colonic transit. Less bloating but no significant change in pain scores. Not associated with ischemic colitis. 5HT 3 Antagonist: Alosetron Most favorable in women with severe IBS and diarrhea who have not responded to conventional therapies (Grade 1B). Potentially serious side effects: (Grade 2A) Constipation: 0.66 per 1,000 patients years Colon ischemia: 1.1 cases per 1,000 patient years Garsed K et al. Gut 2014; 63: Cromolyn Sodium Placebos without Deception No therapies proven to be effective specifically for the management of PI IBS. Marshall, JK et al. World J Gastro, 2009 August 7; 15(29): Kaptchuk TJ et al. PLoS ONE 2010; 5(12):e

4 Your patient comes to you during your next clinic visit requesting rifaximin for treatment of her IBS D. Antibiotics: Rifaximin What would you advise her? 1. Prescribe her rifaximin as requested 2. Advise her to consider a trial of antispasmotics first for her symptoms 3. Send her for formal breath testing to evaluate for small intestinal bacterial overgrowth (SIBO) prior to initiating antibiotics 4. Refer her to GI Pimentel M. et al. NEJM 2011;364(1): Rifaximin Two phase III trials in 1260 IBS patient Significant improvement in global symptoms, bloating, abdominal pain and stool consistency compared to placebo for up to 3 months. Safety profile during and after treatment comparable to placebo. Pimentel M. et al. NEJM 2011;364(1):

5 Compare Rifaximin to Others Role of SIBO in IBS Spiegel BMR. Clinical Gastro and Hep, 2011;9: Spiegel BMR. Clinical Gastro and Hep, 2011;9: Validity of Breath Testing for SIBO Small Intestinal Bacterial Overgrowth Rapid Oro Cecal Transit Time Yu, D et al. Gut, 2011;60:

6 Let s say you decided to prescribe your patient a course of rifaximin which completely alleviates her symptoms. Six months later, her symptoms return and she asks for another prescription for rifaximin. What would your next best course of action be? 1. Prescribe her another course of rifaximin as requested 2. Tell her there is no benefit for another course of antibiotics 3. Send her for formal breath testing to evaluate for small intestinal bacterial overgrowth (SIBO) 4. Refer her to GI for jejunal aspirates to evaluate for SIBO Rifaximin Re Treatment Can be safely and effectively used to re treat patients who have relapsed after already being treated. Of the 42% of patients who responded initially to rifaximin, 36% did not experience symptom recurrence at 18 weeks post treatment. Re treatment response was better in patients treated with rifaximin than with placebo (33% vs 25%; p = 0.02) 2 nd re treatment: 37% vs 29%; p = 0.04 Adverse events similar in two groups. Lembo A et al. Target 3: Rifaximin Safe for Reuse for Irritable Bowel Syndrome. Presented at American College of Gastroenterology 2014 Annual Scientific Meeting, October 21, 2014, Philadellphia, PA. Your patient s stool frequency and urgency has improved but she continues to feel pretty anxious which seems to exacerbate her abdominal pain. You plan on starting an antidepressant. Which one would you start? 1. Lexapro 2. Mirtazapine 3. Amitriptyline 4. Desipramine 5. St. John s Wort Antidepressants Tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs) are more effective than placebo at relieving global IBS symptoms and appear to reduce abdominal pain (Grade 1B). Given their differential effects on intestinal transit time: TCAs: IBS D SSRIs: IBS C However, lack of available data from clinical trials to assess this clinical impression. 6

7 Mirtazapine? Ford, AC et al. AJG, 2014; 109: Antidepressant with noradrenergic and specific serotonergic activity Potent 5HT 3 receptor antagonist Evidence that this pathway modulates visceral perception at the CNS level. Pain relief from somatic symptoms well documented. May contribute to indirect involvement of the opioid system supraspinally Spiegel DR et al. Clin Neuropharm, 2011; 34: St. John s Wort Greater improvement in placebo group Herbal Medicines Meta analysis in 2008 included 22 studies with 25 different herbal medicines. Only 4 considered good quality. Medication Effectiveness Pricing Tong Xie Yao Fang Inconclusive STW 5 Maybe Peppermint Oil Yes: less abd distention, stool $0.05/day frequency, flatulence and abd pain. Padma Lax IBS C: less constipation, abd pain, incomplete evacuation, flatus, distention. $0.75/day St. John s Wort Greater improvement in placebo group $0.09/day LemboAJ. ACG Post Graduate Course LemboAJ. ACG Post Graduate Course

8 Let s say this patient has IBS constipation (IBS C) instead. She is most bothered by her abdominal pain. Which of the following options has NOT been shown to reduce abdominal pain/discomfort in IBS C? Fiber Non digestible carbohydrates that increase stool bulk and water content resulting in decreased stool consistency and increased stool frequency. 1. Fiber 2. Lubiprostone 3. Linaclotide 4. Miralax 5. Tegaserod Psyllium/Oat Bran/Ispaghula Guar Gum Wheat Bran Calcium Polycarbophil Methylcellulose Fiber WARNING: Fiber Adverse Effects Psyllium/Ispaghula /Oat Bran Moderately effective in stool frequency and consistency in IBS C and IBS M Grade 2C Bloating, abdominal distention, flatulence Gradual titration advised, if used. Wheat Bran No more effective than placebo in relief of global IBS symptoms Grade 2C Guar Gum, Calcium Polycarbophil, methylcellulose A single study reported improvement with calcium polycarbophil Insufficien t evidence Eswaran S., et al. AJG, 2013; 108: Chey et al. Gut Liver 2011;5:

9 Laxatives PEG laxative was superior to placebo for relief of constipation but no change in abdominal pain/discomfort (Grade 1B). # of SBMs: Baseline > Week 4 PEG arm: 1.28±0.91 > 4.40±2.58 Placebo: 1.37±0.85 > 3.11±1.94 Other commonly used laxatives therapies (stimulants, stool softeners) have not been adequately studied as a treatment for IBS C. Prosecretory Agents Chapman et al. Am J Gastroenterology 2013; 108: Prosecretory Agent: More effective than placebo in relieving global IBS symptoms in women with IBS C (Grade 1B). Dosage: 8 to 24 μg BID Most common side effects: nausea, diarrhea, HA Chey et al. Gut Liver 2011;5:

10 Prosecretory Agent: In two phase III clinical trials on IBS C patients, linaclotide treatment resulted in significantly greater percentages of patients who experienced improvements in abdominal and bowel symptoms compared to placebo. 33.7% linaclotide vs 13.9% placebo response Effects within 1 st week of treatment and sustained over entire 26 week treatment period. Main side effect: diarrhea Chey et al. AJG 2012;107(11): Yu SWB et al. Therap Adv Gastroenterol 2014;7(5): Prokinetics: Tegaserod (5 HT4 agonist) More effective than placebo for global IBS symptoms as well as abdominal pain and constipation in IBS C and IBS M (Grade 1A/B). Adverse Events: Increased incidence of cardiovascular and cerebrovascular events 0.01% versus 0.01% Colonic ischemia Withdrawn from US and Canada in 2009 Questions? JZia@medicine.washington.edu Chey et al. Gut Liver 2011;5:

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